Overactive bladder (OAB) and fecal incontinence (FI) are well known, non-life threatening conditions. The major symptoms of OAB include urgency, frequent urination, nocturia (interruption of sleep to urinate) and urge incontinence (unintentionally urinating followed urge to continue). FI, also called faecal incontinence, bowel incontinence and anal incontinence, is a lack of control over defecation, leading to involuntary loss of bowel contents—including flatus, liquid stool elements and mucus, or solid feces.
There are generally two types or treatment. The first type of treatment, is a stimulator implant which is a small device surgically implanted under the skin. The stimulator implant transmits electrical pulses to the sacral nerves in the lower back which stimulate the nerves that that control the bladder.
The second type of treatment is Percutaneous tibial nerve stimulation (PTNS). PTNS requires a needle be inserted a couple of inches into the area proximate or above the ankle (medial malleolus). A grounding pad is attached to the patient's foot near the heel. The needle is in turned attached to a Transcutaneous electrical nerve stimulation (TENS) which creates electrical pulses used to treat OAB and/or FI. In general, patients choose not to insert needles into themselves and are leery that the needle would be inserted in the correct location. Therefore, the patient schedules an appointment with a medical practitioner, who inserts the needle and applies the stimulation.
FIG. 1 illustrates application of such a TENS device to provide PTNS. Specifically, the TENS device includes a pulse generator 1 coupled to a first end of pair of leads 2 and 3. The other end of lead 2 is coupled to a clip 4, which is similar to an alligator clip. The clip 4 is employed to make an electrical connection between lead 2 and a needle electrode 5. The needle electrode 5 may be in the form of an acupuncture needle. As described below, the needle electrode 5 penetrates the skin at an insertion site 6. The other end of lead 3 is coupled to a surface electrode such as a patch 7 temporarily placed in contact and/or adhered to the bottom of the patient's foot 8. When in use, the pulse generator sends electrical pulses to the needle electrode 5 which pass through the tibial nerve. The patch electrode 7 and lead 3 provide a ground. The electrical pulses stimulate the tibial nerve, thus, providing therapy.
Superior results are achieved if the needle electrode 5 is inserted such that the electrode 5 resides adjacent the tibial nerve. FIG. 2 illustrates the proper injection 6 which has been marked as an X 10 on a patient's skin using a marking pen. As shown in FIG. 2, the tibial nerve of an adult human is typically located approximately 5 cm (2 inches) cephald (toward the heart) to the middle aspect of the medical malleolus (i.e., the ankle bone) 12 approximately 1 to 2 cm (¾) posterior (behind) to the tibia 14. Insertion of the needle electrode into the medial (inner) aspect of the leg at this location has proven to be efficacious when provided PTNS therapy. This is true whether the left of right leg is employed.
It would therefore be desirable to have a device that properly aligns needle for insertion at this location.